Orthofix Enrolls First Patient in Knee OA Study
Orthofix enrolled the first patient in a study evaluating use of Physio-Stim pulsed electromagnetic field (PEMF) technology to treat knee osteoarthritis (OA). Specifically, the study will assess the system in reducing inflammation and restoring homeostasis of the extracellular matrix, potentially providing symptomatic relief of OA pain, reducing cartilage breakdown and stimulating new cartilage formation.
The prospective, randomized, double-blind, placebo-controlled feasibility trial will enroll ~150 patients at 3 U.S. sites. If successful, this would be the first disease-modifying treatment for osteoarthritis.
Physio-Stim is approved by FDA for the treatment of nonunion fractures. Use in the OA study is investigational and is conducted under an Investigational Device Exemption.
At 1H16, OFIX reported Bone Stim segment growth at +9.4% vs. 1H15. Strength in net BioStim sales is expected to continue throughout 2016, though growth will return to mid-single-digits in the face of year-over-year comps.
Sources: Orthofix Int'l. N.V.; ORTHOWORLD Inc.